ALLEGAN — Perrigo Co. (Nasdaq: PRGO;TASE) announced that it has received a final “Approval for Registration” letter from the Australian Therapeutic Goods Administration, permitting the company to sell generic temozolomide in Australia The letter also states that bioequivalence was met between the brand product, Temodar, and the Company’s generic temozolomide, enabling listing on the Pharmaceutical Benefits Scheme or PBS.
Perrigo’s product is the generic equivalent to Schering-Plough’s Temodar, indicated for patients with malignant glioma. The product is currently generating more than $20 million in sales in Australia. Glioma is the most common primary malignant brain tumor in adults, responsible for 75 percent of adult primary malignant brain tumors. Perrigo’s product provides a quality alternative, making cancer therapy more cost effective for the Australians that suffer from glioma.
“This approval is an excellent example of the Company’s geographic diversification and international capabilities,” said Perrigo chairman and CEO Joseph C. Papa. “We look forward to providing this quality, affordable product to the people of Australia.”
Perrigo develops, manufactures and distributes over-the-counter and generic prescription pharmaceuticals, infant formulas, nutritional products, and active pharmaceutical ingredients. The company is the world’s largest manufacturer of OTC pharmaceutical products and infant formulas, both for the store brand market. The company’s primary markets and locations of manufacturing and logistics operations are the United States, Israel, Mexico, the United Kingdom and Australia.
More at www.perrigo.com.